Formulation and Characterization of Film-Forming Itraconazole Topical Spray for the Treatment of Fungal Infection
Year: 2026
Type: article
Abstract: Background: Fungal infections represent a major public health concern worldwide, as they affect more than a billion patients with superficial infections and more than 150 million people having serious systemic diseases each year. Traditional antifungal cream and ointment preparations suffer from several drawbacks such as poor skin adhesion, uneven distribution of drugs, fast removal of drug from skin surface, and poor compliance.Objective: This study was focused on the development and evaluation of a novel film-forming topical spray (FFTS) of itraconazole (ITZ), a wide spectrum BCS Class II antifungal drug.Methods: Preformulation studies like solubility studies, determination of melting point, and FTIR spectroscopy were carried out for characterization of drug. Development of analytical method for analysis of drug was based on UV-Vis spectrophotometer at 262nm wavelength. Out of seven different film-forming polymers studied for developing FFTS preparation, guar gum was chosen after careful selection. For solvent system optimization, percentage ratio of ethanol to glycerol was varied. Optimized formulation comprised 0.3 % w/v of ITZ, 2 % w/v of guar gum, and ethanol to glycerol 8:2 v/v.Results: The optimal formula resulted in production of a clear, homogeneous, non-sticky, and easily removable film. Some of the physicochemical properties of this formula are pH 6.51 (compatible with physiological conditions), viscosity 150.2 cP (ideal for spraying), spray angle 71.6° (less than 85°, implying suitability for spraying), and volume of each actuation 0.28 mL. The drug loading was 89.6 ± 2.0%. The in vitro cumulative drug release from FFTS was 80.2% during 10 hours of study whereas drug solution release from the solution was 99.36% within seven hours, indicating a sustained release pattern. No major variations were recorded after one month storage.Conclusion: A stable and effective itraconazole film forming topical spray has been formulated utilizing guar gum as a naturally obtained and safe polysaccharide. It provides a novel, efficacious, and sustainable drug delivery system along with improved skin adhesion and compliance in patients.
Author: Astha Suthar
Language: English
Subfield: Pharmaceutical Science
Domain: Life Sciences
Open Access status: hybrid
Estimated APC paid: $3,620
OpenAlex ID: W7155367153